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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-005375-91 | EudraCT Number | ||
| U1111-1164-8495 | Other Identifier | WHO |
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This trial is conducted in Asia, Europe and the United States of America (USA). The aim of the trial is to investigate efficacy and safety of semaglutide versus dulaglutide as add-on to metformin in subjects with type 2 diabetes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Semaglutide 0.5 mg/Week | Experimental |
| |
| Semaglutide 1.0 mg/Week | Experimental |
| |
| Dulaglutide 0.75 mg/Week | Active Comparator |
| |
| Dulaglutide 1.5 mg/Week | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| semaglutide | Drug | Administered subcutaneously (s.c., under the skin) once-weekly. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c | Results are based on HbA1c data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on-treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit. | Week 0, week 40 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Body Weight (kg) | Results are based on body weight data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. |
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Inclusion Criteria: - Male or female, age at least 18 years at the time of signing informed consent. - HbA1c (glycosylated haemoglobin) 7.0 - 10.5% (53 - 91 mmol/mol) (both inclusive) - Subjects on stable diabetes treatment with metformin (minimum of 1500 mg/day or maximal tolerated dose documented in the patient medical record) for 90 days prior to screening Exclusion Criteria: - Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice) - Any condition, which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol - Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 90 days before screening. An exception is short-term insulin treatment for acute illness for a total of equal to or below 14 days - History of pancreatitis (acute or chronic) - Screening calcitonin equal to or above 50 ng/L - Family or personal history of Multiple Endocrine Neoplasia Type 2 or Medullary Thyroid Carcinoma - Renal impairment defined as eGFR (electronic case report form) below 60 mL/min/1.73 m^2 as per CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) - Subjects presently classified as being in New York Heart Association Class IV - Planned coronary, carotid or peripheral artery revascularisation on the day of screening - Proliferative retinopathy or maculopathy requiring acute treatment - History or presence of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer and in-situ carcinomas) - Anticipated initiation or change in concomitant medications (for more than 14 consecutive days or on a frequent basis) known to affect weight or glucose metabolism (e.g. orlistat, thyroid hormones, corticosteroids)
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Tuscumbia | Alabama | 35674 | United States | ||
| Novo Nordisk Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30865526 | Background | Rodbard HW, Bellary S, Hramiak I, Seino Y, Silver R, Damgaard LH, Nayak G, Zacho J, Aroda VR. GREATER COMBINED REDUCTIONS IN HbA1C >/=1.0% AND WEIGHT >/=5.0% WITH SEMAGLUTIDE VERSUS COMPARATORS IN TYPE 2 DIABETES. Endocr Pract. 2019 Jun;25(6):589-597. doi: 10.4158/EP-2018-0444. Epub 2019 Mar 13. | |
| 30927241 | Background |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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A total of 210 sites were approved for recruiting subjects, of which 196 sites randomized the subjects: Bulgaria: 6; Croatia: 6; Finland: 6; Germany: 6; Greece: 8; Hong Kong: 1; India: 22; Ireland: 5; Latvia: 3; Lithuania: 5; Portugal: 4; Romania: 7; Slovakia: 6; Spain: 8; United Kingdom: 8; United States: 95.
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| ID | Title | Description |
|---|---|---|
| FG000 | Semaglutide 0.5 mg | Subjects received subcutaneous (s.c., under the skin) injections of semaglutide once weekly (OW) for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40). |
| FG001 | Semaglutide 1.0 mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 30, 2017 | Apr 9, 2018 |
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| Dulaglutide | Drug | Administered subcutaneously (s.c., under the skin) once-weekly. |
|
| Week 0, week 40 |
| Change in Fasting Plasma Glucose | Results are based on fasting plasma glucose data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. | Week 0, week 40 |
| Change in Systolic and Diastolic Blood Pressure | Results are based on systolic and diastolic blood pressure data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. | Week 0, week 40 |
| Change in Overall Scores for Patient Reported Outcomes: Diabetes Treatment Satisfaction Questionnaire | The questionnaire contains 8 items and evaluates subjects' diabetes treatment in terms of convenience, flexibility and general feelings towards treatment. The result presented is 'Treatment Satisfaction' summary score (sum of 6 of the 8 items). Response options: 6 (best case) to 0 (worst case). Total scores range: 0-36. Higher scores=higher satisfaction. Results are based on data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was period where subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This includes observations recorded at, or after the date of first dose of trial product and not after first occurrence of following: the end-date of the 'on-treatment' observation period or initiation of rescue medication | Week 0, week 40 |
| HbA1c Below or Equal to 6.5% (48 mmol/Mol) American Association of Clinical Endocrinologists Target | Percentage of subjects who achieved HbA1c target below or equal to 6.5% (48 mmol/mol) after 40 weeks of treatment. Results are based on data from on-treatment without rescue medication period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. Missing data imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit. | After 40 weeks treatment |
| Change From Baseline in 7-point Self-measured Plasma Glucose (SMPG) Mean Profile | SMPG values were recorded at 7 time-points: before and 90 minutes after start of breakfast, lunch, and dinner, and at bedtime. Reported results are mean profile from on-treatment without rescue medication observation period. The 'on-treatment' observation period was period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit. | Week 0, week 40 |
| Change From Baseline 7-point Self-measured Plasma Glucose Increment | SMPG values were recorded at 7 time-points: before and 90 minutes after start of breakfast, lunch, and dinner, and at bedtime. Reported results are plasma glucose incremental profile from on-treatment without rescue medication observation period. The 'on-treatment' observation period was period where subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes observations recorded at, or after date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit | Week 0, week 40 |
| Change in Fasting Blood Lipids (Total Cholesterol) | Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit. Change from baseline is presented in terms of ratio to baseline value. | Week 0, week 40 |
| Change in Fasting Blood Lipids (Low Density Lipoprotein [LDL] Cholesterol) | Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit. Change from baseline is presented in terms of ratio to baseline value. | Week 0, week 40 |
| Change in Fasting Blood Lipids (High Density Lipoprotein [HDL] Cholesterol) | Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit. Change from baseline is presented in terms of ratio to baseline value. | Week 0, week 40 |
| Change in Fasting Blood Lipids (Triglycerides) | Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit. Change from baseline is presented in terms of ratio to baseline value. | Week 0, week 40 |
| Change in Body Mass Index (BMI) | Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit. | Week 0, week 40 |
| Change in Waist Circumference | Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit. | Week 0, week 40 |
| Change in Short Form Health Survey (SF-36v2™) | The questionnaire contains 36 items across 8 domains and 2 summary scores. Score range: 0 (worst score) to 100 (best score). Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was period where subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit. | Week 0, week 40 |
| Subjects Who After 40 Weeks Treatment Achieve (Yes/no) HbA1c <7.0% (53 mmol/Mol) American Diabetes Association (ADA) Target | Percentage of subjects who achieved HbA1c target below or equal to <7.0% (53 mmol/mol) after 40 weeks of treatment. Results are based on data from on-treatment without rescue medication period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. Missing data imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit. | After 40 weeks of treatment |
| Subjects Who After 40 Weeks Treatment Achieve (Yes/no) Weight Loss ≥5% | Percentage of subjects who achieved weight loss ≥5% after 40 weeks of treatment. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. Missing data imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit. | After 40 weeks treatment |
| Subjects Who After 40 Weeks Treatment Achieve (Yes/no) Weight Loss ≥10% | Percentage of subjects who achieved weight loss ≥10% after 40 weeks of treatment. Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. Missing data imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit. | After 40 weeks treatment |
| Subjects Who After 40 Weeks Treatment Achieve (Yes/no) HbA1c <7.0% (53 mmol/Mol) Without Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain | Percentage of subjects achieved (yes/no) HbA1c <7.0% (53 mmol/mol) without severe or BG confirmed symptomatic hypoglycaemia episodes and no weight gain after 40 weeks of treatment. Results are based on data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was period where subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was subset of 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. Missing data imputed from mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit | After 40 weeks of treatment |
| Subjects Who After 40 Weeks Treatment Achieve (Yes/no) HbA1c Reduction ≥1% | Percentage of subjects who achieved (yes/no) HbA1c reduction of ≥1% after 40 weeks of treatment. Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. Missing data imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit. | After 40 weeks of treatment |
| Subjects Who After 40 Weeks Treatment Achieve (Yes/no) Weight Loss ≥3% | Percentage of subjects who achieved (yes/no) weight loss of ≥3% after 40 weeks of treatment. Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. Missing data imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit. | After 40 weeks treatment |
| Subjects Who After 40 Weeks Treatment Achieve (Yes/no) HbA1c Reduction ≥1% and Weight Loss ≥3% | Percentage of subjects who achieved (yes/no) HbA1c reduction ≥1% and weight loss ≥3% 40 weeks of treatment. Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. Missing data imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit. | After 40 weeks treatment |
| Number of Treatment Emergent Adverse Events (TEAEs) | A TEAE was defined as an AE with onset in the 'on-treatment' period (information collected while subjects were considered as exposed to trial product). This corresponded to information collected until the follow-up (5 weeks after the last treatment including a visit window of +7 days). | 40 weeks + follow-up of 5 weeks |
| Number of Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemia Episodes | A treatment emergent hypoglycaemic episode was defined as an episode with onset in the 'on-treatment' period (information collected while subjects were considered as exposed to trial product). This corresponded to information collected until the follow-up (5 weeks after the last treatment including a visit window of +7 days). Severe or BG-confirmed symptomatic hypoglycaemia was defined as an episode that was severe according to the American Diabetes Association classification or BG-confirmed by a plasma glucose value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. | 40 weeks + follow-up of 5 weeks |
| Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes | Percentage of subjects with treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes. A treatment emergent hypoglycaemic episode was defined as an episode with onset in the 'on-treatment' period (information collected while subjects were considered as exposed to trial product). This corresponded to information collected until the follow-up (5 weeks after the last treatment including a visit window of +7 days). Severe or BG-confirmed symptomatic hypoglycaemia was defined as an episode that was severe according to the American Diabetes Association classification or BG-confirmed by a plasma glucose value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. | 40 weeks + follow-up of 5 weeks |
| Change in Amylase | Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit. Change from baseline is presented in terms of ratio to baseline value. | Week 0, week 40 |
| Change in Lipase | Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit. Change from baseline is presented in terms of ratio to baseline value. | Week 0, week 40 |
| Change in Pulse Rate | Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit. | Week 0, week 40 |
| Chandler |
| Arizona |
| 85224 |
| United States |
| Novo Nordisk Investigational Site | Phoenix | Arizona | 85032 | United States |
| Novo Nordisk Investigational Site | Phoenix | Arizona | 85050 | United States |
| Novo Nordisk Investigational Site | Anaheim | California | 92801 | United States |
| Novo Nordisk Investigational Site | Buena Park | California | 90620 | United States |
| Novo Nordisk Investigational Site | Carlsbad | California | 92008 | United States |
| Novo Nordisk Investigational Site | Concord | California | 94520 | United States |
| Novo Nordisk Investigational Site | Huntington Park | California | 90255 | United States |
| Novo Nordisk Investigational Site | Lincoln | California | 95648 | United States |
| Novo Nordisk Investigational Site | Los Angeles | California | 90057 | United States |
| Novo Nordisk Investigational Site | Montclair | California | 91763 | United States |
| Novo Nordisk Investigational Site | Poway | California | 92064 | United States |
| Novo Nordisk Investigational Site | Riverside | California | 92506 | United States |
| Novo Nordisk Investigational Site | San Diego | California | 92103 | United States |
| Novo Nordisk Investigational Site | Tustin | California | 92780 | United States |
| Novo Nordisk Investigational Site | Van Nuys | California | 91405 | United States |
| Novo Nordisk Investigational Site | Denver | Colorado | 80220 | United States |
| Novo Nordisk Investigational Site | Norwalk | Connecticut | 06851 | United States |
| Novo Nordisk Investigational Site | Clearwater | Florida | 33756 | United States |
| Novo Nordisk Investigational Site | Clearwater | Florida | 33761 | United States |
| Novo Nordisk Investigational Site | Coral Gables | Florida | 33134 | United States |
| Novo Nordisk Investigational Site | Edgewater | Florida | 32132 | United States |
| Novo Nordisk Investigational Site | Fort Lauderdale | Florida | 33316 | United States |
| Novo Nordisk Investigational Site | Kissimmee | Florida | 34741 | United States |
| Novo Nordisk Investigational Site | Miami | Florida | 33173 | United States |
| Novo Nordisk Investigational Site | Orlando | Florida | 32804 | United States |
| Novo Nordisk Investigational Site | Orlando | Florida | 32806 | United States |
| Novo Nordisk Investigational Site | Pembroke Pines | Florida | 33027 | United States |
| Novo Nordisk Investigational Site | Port Orange | Florida | 32127 | United States |
| Novo Nordisk Investigational Site | Tampa | Florida | 33614 | United States |
| Novo Nordisk Investigational Site | Tampa | Florida | 33634 | United States |
| Novo Nordisk Investigational Site | Adairsville | Georgia | 30103 | United States |
| Novo Nordisk Investigational Site | Atlanta | Georgia | 30342 | United States |
| Novo Nordisk Investigational Site | Bainbridge | Georgia | 39819 | United States |
| Novo Nordisk Investigational Site | Conyers | Georgia | 30094-5965 | United States |
| Novo Nordisk Investigational Site | Marietta | Georgia | 30060 | United States |
| Novo Nordisk Investigational Site | Marietta | Georgia | 30067 | United States |
| Novo Nordisk Investigational Site | Suwanee | Georgia | 30024 | United States |
| Novo Nordisk Investigational Site | Meridian | Idaho | 83646 | United States |
| Novo Nordisk Investigational Site | Addison | Illinois | 60101 | United States |
| Novo Nordisk Investigational Site | Chicago | Illinois | 60607 | United States |
| Novo Nordisk Investigational Site | Gillespie | Illinois | 62033 | United States |
| Novo Nordisk Investigational Site | Gurnee | Illinois | 60031 | United States |
| Novo Nordisk Investigational Site | Peoria | Illinois | 61602 | United States |
| Novo Nordisk Investigational Site | Avon | Indiana | 46123 | United States |
| Novo Nordisk Investigational Site | Evansville | Indiana | 47714 | United States |
| Novo Nordisk Investigational Site | Greenfield | Indiana | 46140 | United States |
| Novo Nordisk Investigational Site | Indianapolis | Indiana | 46254 | United States |
| Novo Nordisk Investigational Site | Muncie | Indiana | 47304 | United States |
| Novo Nordisk Investigational Site | Newton | Kansas | 67114 | United States |
| Novo Nordisk Investigational Site | Park City | Kansas | 67219 | United States |
| Novo Nordisk Investigational Site | Covington | Kentucky | 41011 | United States |
| Novo Nordisk Investigational Site | Louisville | Kentucky | 40213 | United States |
| Novo Nordisk Investigational Site | Owensboro | Kentucky | 42303 | United States |
| Novo Nordisk Investigational Site | Hyattsville | Maryland | 20782 | United States |
| Novo Nordisk Investigational Site | Oxon Hill | Maryland | 20745 | United States |
| Novo Nordisk Investigational Site | Methuen | Massachusetts | 01844 | United States |
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| Johansen P, Hakan-Bloch J, Liu AR, Bech PG, Persson S, Leiter LA. Cost Effectiveness of Once-Weekly Semaglutide Versus Once-Weekly Dulaglutide in the Treatment of Type 2 Diabetes in Canada. Pharmacoecon Open. 2019 Dec;3(4):537-550. doi: 10.1007/s41669-019-0131-6. |
| 31168765 | Background | Malkin SJP, Russel-Szymczyk M, Psota M, Hlavinkova L, Hunt B. The Management of Type 2 Diabetes with Once-Weekly Semaglutide Versus Dulaglutide: A Long-Term Cost-Effectiveness Analysis in Slovakia. Adv Ther. 2019 Aug;36(8):2034-2051. doi: 10.1007/s12325-019-00965-y. Epub 2019 Jun 5. |
| 29397376 | Result | Pratley RE, Aroda VR, Lingvay I, Ludemann J, Andreassen C, Navarria A, Viljoen A; SUSTAIN 7 investigators. Semaglutide versus dulaglutide once weekly in patients with type 2 diabetes (SUSTAIN 7): a randomised, open-label, phase 3b trial. Lancet Diabetes Endocrinol. 2018 Apr;6(4):275-286. doi: 10.1016/S2213-8587(18)30024-X. Epub 2018 Feb 1. |
| 29246950 | Result | Ahmann AJ, Capehorn M, Charpentier G, Dotta F, Henkel E, Lingvay I, Holst AG, Annett MP, Aroda VR. Efficacy and Safety of Once-Weekly Semaglutide Versus Exenatide ER in Subjects With Type 2 Diabetes (SUSTAIN 3): A 56-Week, Open-Label, Randomized Clinical Trial. Diabetes Care. 2018 Feb;41(2):258-266. doi: 10.2337/dc17-0417. Epub 2017 Dec 15. |
| 29764222 | Result | Sharma R, Wilkinson L, Vrazic H, Popoff E, Lopes S, Kanters S, Druyts E. Comparative efficacy of once-weekly semaglutide and SGLT-2 inhibitors in type 2 diabetic patients inadequately controlled with metformin monotherapy: a systematic literature review and network meta-analysis. Curr Med Res Opin. 2018 Sep;34(9):1595-1603. doi: 10.1080/03007995.2018.1476332. Epub 2018 May 29. |
| 29557057 | Result | Wilkinson L, Hunt B, Johansen P, Iyer NN, Dang-Tan T, Pollock RF. Cost of Achieving HbA1c Treatment Targets and Weight Loss Responses with Once-Weekly Semaglutide Versus Dulaglutide in the United States. Diabetes Ther. 2018 Jun;9(3):951-961. doi: 10.1007/s13300-018-0402-8. Epub 2018 Mar 19. |
| 30615985 | Result | Aroda VR, Ahmann A, Cariou B, Chow F, Davies MJ, Jodar E, Mehta R, Woo V, Lingvay I. Comparative efficacy, safety, and cardiovascular outcomes with once-weekly subcutaneous semaglutide in the treatment of type 2 diabetes: Insights from the SUSTAIN 1-7 trials. Diabetes Metab. 2019 Oct;45(5):409-418. doi: 10.1016/j.diabet.2018.12.001. Epub 2019 Jan 4. |
| 30362224 | Result | Viljoen A, Hoxer CS, Johansen P, Malkin S, Hunt B, Bain SC. Evaluation of the long-term cost-effectiveness of once-weekly semaglutide versus dulaglutide for treatment of type 2 diabetes mellitus in the UK. Diabetes Obes Metab. 2019 Mar;21(3):611-621. doi: 10.1111/dom.13564. Epub 2018 Nov 28. |
| 38777128 | Derived | Osumili B, Fan L, Paik JS, Pantalone KM, Ranta K, Sapin H, Tofe S. Tirzepatide 5, 10 and 15 mg versus injectable semaglutide 0.5 mg for the treatment of type 2 diabetes: An adjusted indirect treatment comparison. Diabetes Res Clin Pract. 2024 Jun;212:111717. doi: 10.1016/j.diabres.2024.111717. Epub 2024 May 21. |
| 33199417 | Derived | Pratley RE, Aroda VR, Catarig AM, Lingvay I, Ludemann J, Yildirim E, Viljoen A. Impact of patient characteristics on efficacy and safety of once-weekly semaglutide versus dulaglutide: SUSTAIN 7 post hoc analyses. BMJ Open. 2020 Nov 16;10(11):e037883. doi: 10.1136/bmjopen-2020-037883. |
| 31769496 | Derived | DeSouza C, Cariou B, Garg S, Lausvig N, Navarria A, Fonseca V. Efficacy and Safety of Semaglutide for Type 2 Diabetes by Race and Ethnicity: A Post Hoc Analysis of the SUSTAIN Trials. J Clin Endocrinol Metab. 2020 Feb 1;105(2):dgz072. doi: 10.1210/clinem/dgz072. |
| 31215727 | Derived | Jendle J, Birkenfeld AL, Polonsky WH, Silver R, Uusinarkaus K, Hansen T, Hakan-Bloch J, Tadayon S, Davies MJ. Improved treatment satisfaction in patients with type 2 diabetes treated with once-weekly semaglutide in the SUSTAIN trials. Diabetes Obes Metab. 2019 Oct;21(10):2315-2326. doi: 10.1111/dom.13816. Epub 2019 Jul 12. |
Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (week 1 to 4) followed by 0.5 mg for another 4 weeks (week 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (week 9-40). Subjects were followed for 5 weeks after completion of treatment period. |
| FG002 | Dulaglutide 0.75 mg | Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period. |
| FG003 | Dulaglutide 1.5 mg | Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period. |
| Exposed |
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| COMPLETED |
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| NOT COMPLETED |
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Full analysis set (FAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in the FAS would contribute to the evaluation "as randomised".
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Semaglutide 0.5 mg | Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40). |
| BG001 | Semaglutide 1.0 mg | Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period. |
| BG002 | Dulaglutide 0.75 mg | Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period. |
| BG003 | Dulaglutide 1.5 mg | Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Glycosylated haemoglobin (Hb1Ac) | Mean | Standard Deviation | percentage of HbA1c |
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| Body weight | Mean | Standard Deviation | kg |
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| Fasting plasma glucose | Number of subjects analysed=subjects with available data of fasting plasma glucose at baseline | Mean | Standard Deviation | mmol/L |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in HbA1c | Results are based on HbA1c data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on-treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit. | Analysis was based on FAS. | Posted | Least Squares Mean | Standard Error | percentage of HbA1c | Week 0, week 40 |
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| Secondary | Change in Body Weight (kg) | Results are based on body weight data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. | Analysis was based on FAS. Number of subjects analysed=number of subjects with available data for body weight. | Posted | Least Squares Mean | Standard Error | kg | Week 0, week 40 |
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| Secondary | Change in Fasting Plasma Glucose | Results are based on fasting plasma glucose data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. | Analysis was based on FAS. Number of participants analysed=number of participants with available data for fasting plasma glucose. | Posted | Least Squares Mean | Standard Error | mmol/L | Week 0, week 40 |
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| Secondary | Change in Systolic and Diastolic Blood Pressure | Results are based on systolic and diastolic blood pressure data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. | Analysis was based on FAS. | Posted | Least Squares Mean | Standard Error | mmHg | Week 0, week 40 |
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| Secondary | Change in Overall Scores for Patient Reported Outcomes: Diabetes Treatment Satisfaction Questionnaire | The questionnaire contains 8 items and evaluates subjects' diabetes treatment in terms of convenience, flexibility and general feelings towards treatment. The result presented is 'Treatment Satisfaction' summary score (sum of 6 of the 8 items). Response options: 6 (best case) to 0 (worst case). Total scores range: 0-36. Higher scores=higher satisfaction. Results are based on data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was period where subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This includes observations recorded at, or after the date of first dose of trial product and not after first occurrence of following: the end-date of the 'on-treatment' observation period or initiation of rescue medication | Analysis was based on FAS. Number of participants analysed=number of participants with available data for diabetes treatment satisfaction questionnaire | Posted | Least Squares Mean | Standard Error | units on a scale | Week 0, week 40 |
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| Secondary | HbA1c Below or Equal to 6.5% (48 mmol/Mol) American Association of Clinical Endocrinologists Target | Percentage of subjects who achieved HbA1c target below or equal to 6.5% (48 mmol/mol) after 40 weeks of treatment. Results are based on data from on-treatment without rescue medication period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. Missing data imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit. | Results are based on the FAS. | Posted | Number | percentage of subjects | After 40 weeks treatment |
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| Secondary | Change From Baseline in 7-point Self-measured Plasma Glucose (SMPG) Mean Profile | SMPG values were recorded at 7 time-points: before and 90 minutes after start of breakfast, lunch, and dinner, and at bedtime. Reported results are mean profile from on-treatment without rescue medication observation period. The 'on-treatment' observation period was period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit. | Analysis was based on FAS. Number of participants analysed=Number of participants analysed=number of participants with available data for 7-point self-measured plasma glucose. | Posted | Least Squares Mean | Standard Error | mmol/L | Week 0, week 40 |
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| Secondary | Change From Baseline 7-point Self-measured Plasma Glucose Increment | SMPG values were recorded at 7 time-points: before and 90 minutes after start of breakfast, lunch, and dinner, and at bedtime. Reported results are plasma glucose incremental profile from on-treatment without rescue medication observation period. The 'on-treatment' observation period was period where subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes observations recorded at, or after date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit | Analysis was based on FAS. Number of participants analysed=number of participants with available data for 7-point self-measured plasma glucose increment. | Posted | Least Squares Mean | Standard Error | mmol/L | Week 0, week 40 |
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| Secondary | Change in Fasting Blood Lipids (Total Cholesterol) | Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit. Change from baseline is presented in terms of ratio to baseline value. | Analysis was based on FAS. Number of participants analysed=number of participants with available data for total cholesterol | Posted | Geometric Least Squares Mean | Standard Error | ratio to baseline | Week 0, week 40 |
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| Secondary | Change in Fasting Blood Lipids (Low Density Lipoprotein [LDL] Cholesterol) | Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit. Change from baseline is presented in terms of ratio to baseline value. | Analysis was based on FAS. Number of participants analysed=number of participants with available data for LDL cholesterol. | Posted | Geometric Least Squares Mean | Standard Error | ratio to baseline | Week 0, week 40 |
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| Secondary | Change in Fasting Blood Lipids (High Density Lipoprotein [HDL] Cholesterol) | Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit. Change from baseline is presented in terms of ratio to baseline value. | Analysis was based on FAS. Number of participants analysed=number of participants with available data for HDL cholesterol. | Posted | Geometric Least Squares Mean | Standard Error | ratio to baseline | Week 0, week 40 |
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| Secondary | Change in Fasting Blood Lipids (Triglycerides) | Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit. Change from baseline is presented in terms of ratio to baseline value. | Analysis was based on FAS. Number of participants analysed=number of participants with available data for triglycerides. | Posted | Geometric Least Squares Mean | Standard Error | ratio to baseline | Week 0, week 40 |
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| Secondary | Change in Body Mass Index (BMI) | Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit. | Analysis was based on FAS. Number of participants analysed=number of participants with available data for BMI. | Posted | Least Squares Mean | Standard Error | kg/m^2 | Week 0, week 40 |
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| Secondary | Change in Waist Circumference | Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit. | Analysis was based on FAS. Number of participants analysed=number of participants with available data for waist circumference. | Posted | Least Squares Mean | Standard Error | cm | Week 0, week 40 |
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| Secondary | Change in Short Form Health Survey (SF-36v2™) | The questionnaire contains 36 items across 8 domains and 2 summary scores. Score range: 0 (worst score) to 100 (best score). Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was period where subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit. | Analysis was based on FAS. Number analysed=number of participants with available data for SF-36. | Posted | Least Squares Mean | Standard Error | units on a scale | Week 0, week 40 |
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| Secondary | Subjects Who After 40 Weeks Treatment Achieve (Yes/no) HbA1c <7.0% (53 mmol/Mol) American Diabetes Association (ADA) Target | Percentage of subjects who achieved HbA1c target below or equal to <7.0% (53 mmol/mol) after 40 weeks of treatment. Results are based on data from on-treatment without rescue medication period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. Missing data imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit. | Analysis was based on FAS. | Posted | Number | percentage of subjects | After 40 weeks of treatment |
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| Secondary | Subjects Who After 40 Weeks Treatment Achieve (Yes/no) Weight Loss ≥5% | Percentage of subjects who achieved weight loss ≥5% after 40 weeks of treatment. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. Missing data imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit. | Analysis was based on FAS. Number of participants analysed=number of participants with available data for body weight. | Posted | Number | percentage of subjects | After 40 weeks treatment |
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| Secondary | Subjects Who After 40 Weeks Treatment Achieve (Yes/no) Weight Loss ≥10% | Percentage of subjects who achieved weight loss ≥10% after 40 weeks of treatment. Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. Missing data imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit. | Analysis was based on FAS. Number of participants analysed=number of participants with available data for body weight | Posted | Number | percentage of subjects | After 40 weeks treatment |
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| Secondary | Subjects Who After 40 Weeks Treatment Achieve (Yes/no) HbA1c <7.0% (53 mmol/Mol) Without Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain | Percentage of subjects achieved (yes/no) HbA1c <7.0% (53 mmol/mol) without severe or BG confirmed symptomatic hypoglycaemia episodes and no weight gain after 40 weeks of treatment. Results are based on data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was period where subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was subset of 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. Missing data imputed from mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit | Analysis was based on FAS. Number of participants analysed=number of participants with available data for this endpoint. | Posted | Number | percentage of subjects | After 40 weeks of treatment |
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| Secondary | Subjects Who After 40 Weeks Treatment Achieve (Yes/no) HbA1c Reduction ≥1% | Percentage of subjects who achieved (yes/no) HbA1c reduction of ≥1% after 40 weeks of treatment. Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. Missing data imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit. | Analysis was based on FAS. | Posted | Number | percentage of subjects | After 40 weeks of treatment |
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| Secondary | Subjects Who After 40 Weeks Treatment Achieve (Yes/no) Weight Loss ≥3% | Percentage of subjects who achieved (yes/no) weight loss of ≥3% after 40 weeks of treatment. Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. Missing data imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit. | Analysis was based on FAS. Number of participants analysed=number of participants with available data for body weight | Posted | Number | percentage of subjects | After 40 weeks treatment |
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| Secondary | Subjects Who After 40 Weeks Treatment Achieve (Yes/no) HbA1c Reduction ≥1% and Weight Loss ≥3% | Percentage of subjects who achieved (yes/no) HbA1c reduction ≥1% and weight loss ≥3% 40 weeks of treatment. Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. Missing data imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit. | Analysis was based on FAS. Number of participants analysed=number of participants with available data for HbA1c and body weight. | Posted | Number | percentage of subjects | After 40 weeks treatment |
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| Secondary | Number of Treatment Emergent Adverse Events (TEAEs) | A TEAE was defined as an AE with onset in the 'on-treatment' period (information collected while subjects were considered as exposed to trial product). This corresponded to information collected until the follow-up (5 weeks after the last treatment including a visit window of +7 days). | Analysis was based on the safety analysis set which included all randomised subjects exposed to at least one dose of trial product. | Posted | Number | events | 40 weeks + follow-up of 5 weeks |
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| Secondary | Number of Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemia Episodes | A treatment emergent hypoglycaemic episode was defined as an episode with onset in the 'on-treatment' period (information collected while subjects were considered as exposed to trial product). This corresponded to information collected until the follow-up (5 weeks after the last treatment including a visit window of +7 days). Severe or BG-confirmed symptomatic hypoglycaemia was defined as an episode that was severe according to the American Diabetes Association classification or BG-confirmed by a plasma glucose value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. | Analysis was based on the safety analysis set which included all randomised subjects exposed to at least one dose of trial product. | Posted | Number | hypoglycaemic episodes | 40 weeks + follow-up of 5 weeks |
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| Secondary | Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes | Percentage of subjects with treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes. A treatment emergent hypoglycaemic episode was defined as an episode with onset in the 'on-treatment' period (information collected while subjects were considered as exposed to trial product). This corresponded to information collected until the follow-up (5 weeks after the last treatment including a visit window of +7 days). Severe or BG-confirmed symptomatic hypoglycaemia was defined as an episode that was severe according to the American Diabetes Association classification or BG-confirmed by a plasma glucose value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. | Analysis was based on the safety analysis set which included all randomised subjects exposed to at least one dose of trial product. | Posted | Number | percentage of subjects | 40 weeks + follow-up of 5 weeks |
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| Secondary | Change in Amylase | Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit. Change from baseline is presented in terms of ratio to baseline value. | Analysis was based on safety analysis set. Number of participants analysed=number of participants with available data for amylase. | Posted | Geometric Least Squares Mean | Standard Error | ratio to baseline | Week 0, week 40 |
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| Secondary | Change in Lipase | Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit. Change from baseline is presented in terms of ratio to baseline value. | Analysis was based on safety analysis set. Number of participants analysed=number of participants with available data for lipase. | Posted | Geometric Least Squares Mean | Standard Error | ratio to baseline | Week 0, week 40 |
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| Secondary | Change in Pulse Rate | Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit. | Analysis was based on safety analysis set. | Posted | Least Squares Mean | Standard Error | beats/min | Week 0, week 40 |
|
Baseline (week 0) to week 40 + follow up of 5 weeks (including a visit window of +7 days)
A TEAE was defined as an AE with onset in the 'on-treatment' period (information collected while subjects were considered as exposed to trial product). This corresponded to information collected from first administration of trial product until the follow-up (5 weeks after the last treatment including a visit window of +7 days)
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Semaglutide 0.5 mg | Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40). | 0 | 301 | 17 | 301 | 132 | 301 |
| EG001 | Semaglutide 1.0 mg | Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period. | 1 | 300 | 23 | 300 | 134 | 300 |
| EG002 | Dulaglutide 0.75 mg | Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period. | 2 | 299 | 24 | 299 | 106 | 299 |
| EG003 | Dulaglutide 1.5 mg | Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period. | 2 | 299 | 22 | 299 | 139 | 299 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 19 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 19 | Systematic Assessment |
| |
| Acute vestibular syndrome | Ear and labyrinth disorders | MedDRA 19 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 19 | Systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA 19 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 19 | Systematic Assessment |
| |
| Aortic valve stenosis | Cardiac disorders | MedDRA 19 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 19 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 19 | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA 19 | Systematic Assessment |
| |
| Atrioventricular block complete | Cardiac disorders | MedDRA 19 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 19 | Systematic Assessment |
| |
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 19 | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA 19 | Systematic Assessment |
| |
| Cardioversion | Surgical and medical procedures | MedDRA 19 | Systematic Assessment |
| |
| Carpal tunnel syndrome | Nervous system disorders | MedDRA 19 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 19 | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA 19 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 19 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 19 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 19 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 19 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 19 | Systematic Assessment |
| |
| Congestive cardiomyopathy | Cardiac disorders | MedDRA 19 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 19 | Systematic Assessment |
| |
| Coronary artery stenosis | Cardiac disorders | MedDRA 19 | Systematic Assessment |
| |
| Crohn's disease | Gastrointestinal disorders | MedDRA 19 | Systematic Assessment |
| |
| Cystocele | Reproductive system and breast disorders | MedDRA 19 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 19 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 19 | Systematic Assessment |
| |
| Diabetic complication | Metabolism and nutrition disorders | MedDRA 19 | Systematic Assessment |
| |
| Diabetic neuropathy | Nervous system disorders | MedDRA 19 | Systematic Assessment |
| |
| Drowning | General disorders | MedDRA 19 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 19 | Systematic Assessment |
| |
| Face injury | Injury, poisoning and procedural complications | MedDRA 19 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 19 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 19 | Systematic Assessment |
| |
| Gallbladder pain | Hepatobiliary disorders | MedDRA 19 | Systematic Assessment |
| |
| Gastrectomy | Surgical and medical procedures | MedDRA 19 | Systematic Assessment |
| |
| Gastroduodenitis | Gastrointestinal disorders | MedDRA 19 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 19 | Systematic Assessment |
| |
| HIV infection | Infections and infestations | MedDRA 19 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 19 | Systematic Assessment |
| |
| Hepatic cirrhosis | Hepatobiliary disorders | MedDRA 19 | Systematic Assessment |
| |
| Hip arthroplasty | Surgical and medical procedures | MedDRA 19 | Systematic Assessment |
| |
| Hospitalisation | Surgical and medical procedures | MedDRA 19 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 19 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 19 | Systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA 19 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 19 | Systematic Assessment |
| |
| Hypoglycaemic unconsciousness | Nervous system disorders | MedDRA 19 | Systematic Assessment |
| |
| Hysterectomy | Surgical and medical procedures | MedDRA 19 | Systematic Assessment |
| |
| Impaired gastric emptying | Gastrointestinal disorders | MedDRA 19 | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA 19 | Systematic Assessment |
| |
| Intervertebral disc degeneration | Musculoskeletal and connective tissue disorders | MedDRA 19 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 19 | Systematic Assessment |
| |
| Kidney infection | Infections and infestations | MedDRA 19 | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA 19 | Systematic Assessment |
| |
| Lipoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19 | Systematic Assessment |
| |
| Malignant neoplasm of ampulla of Vater | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19 | Systematic Assessment |
| |
| Meniscus injury | Injury, poisoning and procedural complications | MedDRA 19 | Systematic Assessment |
| |
| Metastatic squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19 | Systematic Assessment |
| |
| Multiple organ dysfunction syndrome | General disorders | MedDRA 19 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 19 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 19 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 19 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 19 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 19 | Systematic Assessment |
| |
| Orchidectomy | Surgical and medical procedures | MedDRA 19 | Systematic Assessment |
| |
| Pancreatic carcinoma stage IV | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 19 | Systematic Assessment |
| |
| Pancreatolithiasis | Gastrointestinal disorders | MedDRA 19 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 19 | Systematic Assessment |
| |
| Perirectal abscess | Infections and infestations | MedDRA 19 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 19 | Systematic Assessment |
| |
| Post procedural myocardial infarction | Injury, poisoning and procedural complications | MedDRA 19 | Systematic Assessment |
| |
| Postoperative wound infection | Infections and infestations | MedDRA 19 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 19 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 19 | Systematic Assessment |
| |
| Rectal adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19 | Systematic Assessment |
| |
| Rectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19 | Systematic Assessment |
| |
| Rectal prolapse | Gastrointestinal disorders | MedDRA 19 | Systematic Assessment |
| |
| Renal colic | Renal and urinary disorders | MedDRA 19 | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 19 | Systematic Assessment |
| |
| Sarcoidosis | Immune system disorders | MedDRA 19 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 19 | Systematic Assessment |
| |
| Spinal column stenosis | Musculoskeletal and connective tissue disorders | MedDRA 19 | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA 19 | Systematic Assessment |
| |
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA 19 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 19 | Systematic Assessment |
| |
| Ureterolithiasis | Renal and urinary disorders | MedDRA 19 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 19 | Systematic Assessment |
| |
| Uterine prolapse | Reproductive system and breast disorders | MedDRA 19 | Systematic Assessment |
| |
| Ventricular extrasystoles | Cardiac disorders | MedDRA 19 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 19 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA 19 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 19 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 19 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 19 | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA 19 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 19 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 19 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 19 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 19 | Systematic Assessment |
|
At the end of the trial, one or more scientific publications may be prepared collaboratively by the investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for up to 60 days to protect intellectual property.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Reporting Anchor and Disclosure (1452) | Novo Nordisk A/S | (+1) 866-867-7178 | clinicaltrials@novonordisk.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 30, 2017 | Apr 9, 2018 | SAP_001.pdf |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000591245 | semaglutide |
| C555680 | dulaglutide |
Not provided
Not provided
Not provided
|
|
|
|
|
|
|
| <0.0001 |
| Treatment difference |
| -0.40 |
| Standard Error of the Mean |
| 0.08 |
| 2-Sided |
| 95 |
| -0.55 |
| -0.25 |
| Superiority |
| Mixed Models Analysis | <0.0001 | Treatment difference | -0.41 | Standard Error of the Mean | 0.08 | 2-Sided | 95 | -0.57 | -0.25 | Non-Inferiority | Non-Inferiority margin: 0.04 |
| Mixed Models Analysis | <0.0001 | Treatment difference | -0.41 | Standard Error of the Mean | 0.08 | 2-Sided | 95 | -0.57 | -0.25 | Superiority |
| OG002 | Dulaglutide 0.75 mg | Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period. |
| OG003 | Dulaglutide 1.5 mg | Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period. |
|
|
|
| OG002 | Dulaglutide 0.75 mg | Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period. |
| OG003 | Dulaglutide 1.5 mg | Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period. |
|
|
| OG002 | Dulaglutide 0.75 mg | Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period. |
| OG003 | Dulaglutide 1.5 mg | Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period. |
|
|
| Semaglutide 1.0 mg |
Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period. |
| OG002 | Dulaglutide 0.75 mg | Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period. |
| OG003 | Dulaglutide 1.5 mg | Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period. |
|
|
| OG002 | Dulaglutide 0.75 mg | Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period. |
| OG003 | Dulaglutide 1.5 mg | Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period. |
|
|
| Semaglutide 1.0 mg |
Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period. |
| OG002 | Dulaglutide 0.75 mg | Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period. |
| OG003 | Dulaglutide 1.5 mg | Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period. |
|
|
Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period. |
| OG002 | Dulaglutide 0.75 mg | Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period. |
| OG003 | Dulaglutide 1.5 mg | Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period. |
|
|
Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period.
| OG002 | Dulaglutide 0.75 mg | Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period. |
| OG003 | Dulaglutide 1.5 mg | Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period. |
|
|
Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period.
| OG002 | Dulaglutide 0.75 mg | Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period. |
| OG003 | Dulaglutide 1.5 mg | Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period. |
|
|
Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period.
| OG002 | Dulaglutide 0.75 mg | Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period. |
| OG003 | Dulaglutide 1.5 mg | Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period. |
|
|
Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period.
| OG002 | Dulaglutide 0.75 mg | Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period. |
| OG003 | Dulaglutide 1.5 mg | Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period. |
|
|
| OG002 | Dulaglutide 0.75 mg | Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period. |
| OG003 | Dulaglutide 1.5 mg | Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period. |
|
|
| OG002 | Dulaglutide 0.75 mg | Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period. |
| OG003 | Dulaglutide 1.5 mg | Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period. |
|
|
Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period.
| OG002 | Dulaglutide 0.75 mg | Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period. |
| OG003 | Dulaglutide 1.5 mg | Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period. |
|
|
| OG002 | Dulaglutide 0.75 mg | Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period. |
| OG003 | Dulaglutide 1.5 mg | Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period. |
|
|
| OG002 | Dulaglutide 0.75 mg | Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period. |
| OG003 | Dulaglutide 1.5 mg | Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period. |
|
|
Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period.
| OG002 | Dulaglutide 0.75 mg | Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period. |
| OG003 | Dulaglutide 1.5 mg | Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period. |
|
|
| OG001 |
| Semaglutide 1.0 mg |
Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period. |
| OG002 | Dulaglutide 0.75 mg | Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period. |
| OG003 | Dulaglutide 1.5 mg | Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period. |
|
|
| OG002 | Dulaglutide 0.75 mg | Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period. |
| OG003 | Dulaglutide 1.5 mg | Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period. |
|
|
Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period.
| OG002 | Dulaglutide 0.75 mg | Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period. |
| OG003 | Dulaglutide 1.5 mg | Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period. |
|
|
Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period. |
| OG002 | Dulaglutide 0.75 mg | Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period. |
| OG003 | Dulaglutide 1.5 mg | Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period. |
|
|
| OG003 | Dulaglutide 1.5 mg | Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period. |
|
|
| OG002 | Dulaglutide 0.75 mg | Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period. |
| OG003 | Dulaglutide 1.5 mg | Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period. |
|
|
| OG002 | Dulaglutide 0.75 mg | Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period. |
| OG003 | Dulaglutide 1.5 mg | Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period. |
|
|
Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period.
| OG002 | Dulaglutide 0.75 mg | Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period. |
| OG003 | Dulaglutide 1.5 mg | Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period. |
|
|
| OG002 | Dulaglutide 0.75 mg | Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period. |
| OG003 | Dulaglutide 1.5 mg | Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period. |
|
|
| OG002 | Dulaglutide 0.75 mg | Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period. |
| OG003 | Dulaglutide 1.5 mg | Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period. |
|
|
|
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